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Palo Alto, CA, December 2, 2003 — Telik, Inc. (Nasdaq:
TELK) announced that the U.S. Food and Drug Administration (FDA)
has granted Fast Track designation for TELCYTA™ (TLK286) for
third line therapy for locally advanced or metastatic non-small
cell lung cancer. The FDA previously granted Fast Track designation
for TELCYTA™ for third line therapy in patients with platinum
refractory or resistant ovarian cancer.
Fast Track programs are designed to facilitate the development
and expedite the review of new drugs that demonstrate the potential
to treat serious or life-threatening conditions and address unmet
medical needs.
Lung cancer results in 28% of all cancer deaths in the U.S., and
it is the leading cause of cancer deaths, according to the American
Cancer Society (ACS). The ACS estimates that 171,900 new cases of
lung cancer will be diagnosed in 2003 and an estimated 157,200 deaths
will result from the disease.
About Telik, Inc.
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company working
to discover, develop and commercialize small molecule drugs to treat
serious diseases for which there is significant demand for new therapies.
The company’s most advanced drug development candidate is
TELCYTA™. Telik’s product candidates were discovered
using its proprietary technology, TRAP, which enables the rapid
and efficient discovery of small molecule drug candidates. Additional
information is available at www.telik.com.
You should not rely on forward-looking statements contained in
this press release, including statements regarding our ability to
successfully develop TELCYTA™ for the treatment of any cancer,
its tolerability, potential efficacy or market potential. Telik
can give no assurance with regard to these statements. None of our
products have been determined to be safe or effective in humans
or been approved for marketing. Substantial additional testing,
including randomized, controlled clinical trials of TELCYTA™
will be necessary prior to seeking marketing approval. There can
be no assurance that such trials will accrue sufficient patients,
be conducted with sufficient quality, in a timely manner, have a
successful outcome, or that regulatory approval will be obtained.
In addition, we are reliant on external manufacturing, and any interruption
or delay in drug supply could adversely affect the development program.
More detailed information regarding factors that may cause actual
results to differ materially from the results expressed or implied
by statements in this press release may be found in Telik’s
periodic filings with the Securities and Exchange Commission. Telik
assumes no obligation to update any information in this press release.
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Contact:
Carol DeGuzman
Senior Director, Corporate Communications
Telik, Inc.
Tel 650-845-7728
Email cdeguzman@telik.com
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